Swallow exerciser

ABSTRACT

A swallow exerciser device that exercises and thereby strengthens the muscles involved in swallowing includes a rigid shell, an adjustable fastener, and an inflatable pad. The rigid shell has a longitudinal dimension such that the shell extends above and below the larynx of the subject when the swallow exerciser device is positioned over the larynx of the subject. The adjustable fastener is dimensioned to secure the shell around a neck of the subject with the shell positioned over the larynx of the subject. The inflatable pad is connected to a proximal surface of the shell. The inflatable pad is dimensioned to apply resistance to force of at least one swallowing muscle of the subject when the shell positioned over the larynx of the subject and when the inflatable pad is in an inflated position. The swallow exerciser device can be used in a method for improving swallowing function in a subject.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 15/502,925, filed Feb. 9, 2017, which is a 371 application ofPCT International Application No. PCT/US2015/044634, filed Aug. 11, 2015which claims priority from U.S. Patent Application No. 62/035,670 filedAug. 11, 2014. The contents of these applications are herebyincorporated by reference as if set forth in their entirety herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

This invention was made with government support under R01DK025731 andP01DK068051 awarded by the National Institutes of Health. The governmenthas certain rights in the invention.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to a device and method for exercising theswallowing muscles.

2. Description of the Related Art

Swallowing is a complicated multi-stage process that involvescoordinated contraction of muscles in the tongue, lips and mouth,pharynx and esophagus, throat and neck. Swallowing can be divided intothree functional stages—oral, pharyngeal, and esophageal.

During the oral phase, food is processed to form a bolus of the rightsize and consistency for transfer. In a rapid sequence, the tonguepresses against the hard palate, generating a pressure wave directedposteriorly that propels the bolus into the oropharynx. Concurrent withthis action, the soft palate elevates, while the cheeks, floor of mouth,and jaw are braced. The oral phase can be considered completed when thebolus tail enters the oropharynx, at which point the posterior dorsum ofthe tongue remains sealed against the soft palate to prevent retrogradeescape of bolus back into the oral cavity.

The pharyngeal phase, or transfer phase, requires the hyoid bone andlarynx to move superior and anterior, which brings the larynx out of thepath of the bolus. Several muscle groups are activated during thepharyngeal phase. Muscles of the tongue are used to seal the oralcavity, while the digastric muscle, geniohyoid, and mylohyoid of thesuprahyoid muscle group work to elevate the hyoid. Additionally, thethyrohyoid muscle of the infrahyoid muscle group moves the thyroidcartilage to the base of the hyoid, consequently elevating the larynxand the upper esophageal sphincter, which is attached to the larynx, by2 to 2.5 centimeters. Anterior movement of the larynx is a factor in theopening of the upper esophageal sphincter. Contraction of thelongitudinal muscle group (palatopharyngeus, stylopharyngeus,salpingopharyngeus) elevates and shortens the pharynx. The action of thestylopharyngeus also widens the pharynx and opposes anterior movement ofthe posterior pharynx. The actions of these muscles elevate the larynxas well. Muscles in the pharyngeal constrictor group (superiorpharyngeal constrictor muscle, middle pharyngeal constrictor muscle,inferior pharyngeal constrictor muscle) form a muscular “tunnel” anddrive food into the esophagus through the already open upper esophagealsphincter, and this action is completed by pharyngeal peristalticcontraction.

Damage to or weakness in the muscles and motor control of variousstructures can result in difficulty in swallowing, i.e., “dysphagia”.Dysphagia can also be the result of damage to sensory nerves or sensoryprocessing from the periphery to the cortex, which can be manifest as areduced awareness of oral or pharyngeal light “touch” and a delay intriggering the pharyngeal swallow. Swallow apraxia, or difficulty inprogramming motor actions during swallow, can also have a sensorycomponent. Dysphagia may occur following stroke and traumatic braininjury, aging and after debilitating illness such as Parkinson'sdisease, multiple sclerosis, amyotrophic lateral sclerosis, and head,neck and esophageal cancer.

Current treatments for dysphagia focus on “strengthening” the musclesinvolved with swallowing “exercises”. Indeed, one of the inventors isknown for the Shaker Exercise which targets the suprahyoid muscles underthe chin. A patient lies flat on the floor or bed and raises his/herhead to look at the toes, holding this position for 60 seconds, similarto a “sit-up”. Other exercises have been developed to strengthen thetongue, lips, and jaw.

U.S. Pat. No. 8,388,561 describes a device for treating a subject withdysphagia or a speech disorder. The device includes a band equipped witha vibrator that is wrapped around the neck and positioned over thelarynx. Upon activation the vibrator vibrates the larynx. The devicecontains an automatic stimulation controller that cycles on and off toinitiate and maintain vibro-tactile stimulation to induce swallowing.The device also includes a movement and or related physiological sensorfor monitoring pressure or movement changes due to elevation of thesubject's larynx during attempts to swallow. In this system, the patient“cues” the system immediately before he/she swallows. The systemdisplays this cue along with the subsequent changes in pressure etc. Thedevice of U.S. Pat. No. 8,388,561 has disadvantages, for example, thedevice utilizes vibratory stimulation to induce swallowing, a sensationthat may be uncomfortable for patients using the device. Additionally,the vibro-tactile stimulation is used to trigger swallowing, an actionnot correlated with natural bodily function.

What is needed therefore is an improved device and method for exercisingthe swallowing muscles and thereby strengthen the muscles involved inpharyngeal phase swallowing.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a swallow exerciser devicefor improving swallowing function in a subject (e.g., a mammal). In onenon-limiting form, the device includes a rigid outer shell, anadjustable fastener, and an inflatable conforming inner pad. The rigidshell has a longitudinal dimension such that the shell extends above alarynx of the subject and extends below the larynx of the subject whenthe swallow exerciser device is positioned over the larynx of thesubject. The shell has a distal surface and a proximal surface. Theadjustable fastener is dimensioned to secure the shell around a neck ofthe subject with the shell positioned over the larynx of the subject.The inflatable pad is connected to the proximal surface of the shell.The inflatable pad is dimensioned to apply resistance to force of atleast one swallowing muscle of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in aninflated position.

In one version of the swallow exerciser device, the adjustable fasteneris connected to the shell. In another version of the swallow exerciserdevice, a spacer (e.g., a bar) is positioned between the shell and theadjustable fastener, and the spacer is attached to the shell and/or theadjustable fastener. In another version of the swallow exerciser device,the spacer is inwardly spaced from a perimeter edge of the shell.

The inflatable pad can be dimensioned to apply resistance to force of atleast one muscle of the tongue of the subject when the shell ispositioned over the larynx of the subject and when the inflatable pad isin the inflated position.

The inflatable pad can be dimensioned to apply resistance to force of atleast one suprahyoid muscle of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in theinflated position.

The inflatable pad can be dimensioned to apply resistance to force of atleast one of the digastric muscle, geniohyoid, and mylohyoid of thesubject when the shell is positioned over the larynx of the subject andwhen the inflatable pad is in the inflated position.

The inflatable pad can be dimensioned to apply resistance to force of atleast one infrahyoid muscle of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in theinflated position.

The inflatable pad can be dimensioned to apply resistance to force of atleast one muscle of a longitudinal muscle group of the subject when theshell is positioned over the larynx of the subject and when theinflatable pad is in the inflated position.

The inflatable pad can be dimensioned to apply resistance to force of atleast one of the palatopharyngeus, stylopharyngeus andsalpingopharyngeus of the subject when the shell is positioned over thelarynx of the subject and when the inflatable pad is in the inflatedposition.

The inflatable pad can be dimensioned to apply resistance to force of atleast one pharyngeal constrictor muscle of the subject when the shell ispositioned over the larynx of the subject and when the inflatable pad isin the inflated position.

The inflatable pad can be dimensioned to increase resistance to a flowof swallowed food out of a pharynx of the subject when the shell ispositioned over the larynx of the subject and when the inflatable pad isin the inflated position.

The inflatable pad can be dimensioned to apply resistance to superiorand anterior movement of the larynx of the subject when the shell ispositioned over the larynx of the subject and when the inflatable pad isin the inflated position.

The inflatable pad can be dimensioned to apply resistance to superiormovement of a hyoid bone of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in theinflated position.

The inflatable pad can be dimensioned to avoid applying pressure to acarotid artery of the subject when the shell is positioned over thelarynx of the subject and when the inflatable pad is in the inflatedposition. The inflatable pad can be dimensioned to avoid applyingpressure to a jugular vein of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in theinflated position.

In one version of the device, a transverse cross-section of the proximalsurface of the shell is concave. In another version of the device, atransverse cross-section of the proximal surface of the shell takenalong a transverse axis of the shell is concave along an entire lengthof the transverse cross-section. In another version of the device, alongitudinal cross-section of the proximal surface of the shell isconcave. In another version of the device, a longitudinal cross-sectionof the proximal surface of the shell taken along a longitudinal axis ofthe shell is concave along an entire length of the longitudinalcross-section. In another version of the device, a transversecross-section of the proximal surface of the shell is concave, alongitudinal cross-section of the proximal surface of the shell isconcave, and the longitudinal cross-section of the proximal surface isless concave than the transverse cross-section of the proximal surface.

In another version of the device, the shell is dimensioned to secure theshell around the neck of the subject such that the shell extends fromcricoid cartilage to thyroid cartilage of the subject along alongitudinal axis of the shell. In another version of the device, theshell is dimensioned to secure the shell around the neck of the subjectsuch that the shell extends from cricoid cartilage to above a hyoid boneof the subject along a longitudinal axis of the shell. In anotherversion of the device, the proximal surface of the shell includes anindentation for receiving the inflatable pad.

In one version of the device, a viscoelastic layer is attached to aproximal side of the inflatable pad. The viscoelastic layer may comprisea shape memory foam. In another version of the device, a proximal layercovers a proximal side of the viscoelastic layer. The proximal layer cancomprise a fabric.

In one version of the device, the device does not trigger swallowing inthe subject. In another version of the device, the device does notinclude a vibrating element. In another version of the device, thedevice does not include an electrical element.

In one version of the device, the adjustable fastener includes ahook-type fastener component and a loop-type fastener component. In oneversion of the device, the device includes an inflation apparatus forinflating and deflating the inflatable pad, wherein the inflationapparatus includes a pump for inflating the inflatable pad, a conduit influid communication with the inflatable pad and the pump, and a valvefor regulating inflation and deflation of the inflatable pad. Theinflation apparatus may further comprise a gage for measuring a pressurelevel in the inflatable pad.

In another aspect, the present invention provides a method for improvingswallowing function in a subject. The method comprises positioning aswallow exerciser device over the larynx of the subject. The swallowexerciser device includes (i) a shell having a longitudinal dimensionsuch that the shell extends above a larynx of the subject and extendsbelow the larynx of the subject wherein the shell has a distal surfaceand a proximal surface, (ii) an adjustable fastener that is dimensionedto secure the shell around a neck of the subject with the shellpositioned over the larynx of the subject, and (iii) an inflatableconforming pad connected to the proximal surface of the shell whereinthe inflatable pad is dimensioned to apply resistance to force of atleast one swallowing muscle of the subject when the shell positionedover the larynx of the subject and when the inflatable pad is in aninflated position. In the method, the subject swallows after positioningthe device over the larynx of the subject. When a subject repeatedlyswallows with the swallow exerciser device positioned as in the methodof the invention, the swallow exerciser device exercises the swallowingmuscles and thereby strengthens the muscles involved in swallowing bymaking them “work harder”.

In one version of the method, the adjustable fastener of the swallowexerciser device is connected to the shell. In another version of themethod, a spacer (e.g., a bar) is positioned between the shell and theadjustable fastener of the swallow exerciser device, and the spacer isattached to the shell and/or the adjustable fastener. In another versionof the method, the spacer of the swallow exerciser device is inwardlyspaced from a perimeter edge of the shell.

In one version of the method, when the inflatable pad is in the inflatedposition, the inflatable pad exerts pressure between the shell and theneck of the subject in a pressure range of 10 to 50 mm Hg. In anotherversion of the method, when the inflatable pad is in the inflatedposition, the inflatable pad exerts pressure between the shell and theneck of the subject in a pressure range of 10 to 40 mm Hg. In anotherversion of the method, when the inflatable pad is in the inflatedposition, the inflatable pad exerts pressure between the shell and theneck of the subject in a pressure range of 10 to 30 mm Hg.

The method may further comprise increasing a pressure in the inflatablepad after the subject swallows at least one time. The method may furthercomprise removing the device after the subject swallows at least onetime with a first pressure in the inflatable pad, and positioning theswallow exerciser device over the larynx of the subject a second timewith a second pressure in the inflatable pad, wherein the secondpressure is greater than the first pressure. The method may furthercomprise removing the device after the subject swallows at least onetime with the second pressure in the inflatable pad, and positioning theswallow exerciser device over the larynx of the subject a third timewith a third pressure in the inflatable pad, wherein the third pressureis greater than the second pressure.

In one version of the method, the device is positioned such that theshell extends about 1 to 2 centimeters above the larynx and the shellextends about 1 to 2 centimeters below the larynx. In another version ofthe method, the device is positioned such that the inflatable padapplies resistance to force of at least one muscle of the tongue of thesubject when the inflatable pad is in the inflated position. In anotherversion of the method, the device is positioned such that the inflatablepad applies resistance to force of at least one suprahyoid muscle of thesubject when the inflatable pad is in the inflated position.

In another version of the method, the device is positioned such that theinflatable pad applies resistance to force of at least one infrahyoidmuscle of the subject when the inflatable pad is in the inflatedposition.

In another version of the method, the device is positioned such that theinflatable pad applies resistance to force of at least one of thepalatopharyngeus, stylopharyngeus and salpingopharyngeus of the subjectwhen the inflatable pad is in the inflated position.

In another version of the method, the device is positioned such that theinflatable pad applies resistance to force of at least one pharyngealconstrictor muscle of the subject when the inflatable pad is in theinflated position.

In one version of the method, the method fatigues a pharynx of thesubject. In another version of the method, the method fatigues aproximal striated esophagus of the subject. In another version of themethod, the method fatigues both a pharynx and a proximal striatedesophagus of the subject. In another version of the method, the methodprovides a resistive load to anterior and superior movement of a hyoidand a larynx of the subject.

It is therefore an advantage of the invention to provide a swallowexerciser device that can be used with the body's natural function(swallowing) to exercise the swallowing muscles.

It is another advantage of the invention to provide a swallow exerciserdevice that does not require the use of a vibrating element or anelectrical element.

It is yet another advantage of the invention to provide a swallowexerciser device that does not trigger swallowing.

By working the swallowing muscles to fatigue with a swallow exerciserdevice of the invention, a user causes an increase in the strength ofthe swallowing muscles.

These and other features, aspects, and advantages of the presentinvention will become better understood upon consideration of thefollowing detailed description, drawings and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a subject wearing a swallow exerciser deviceaccording to one embodiment of the invention.

FIG. 2 is a longitudinal cross-sectional view of the swallow exerciserdevice of FIG. 1 taken along line 2-2 of FIG. 1.

FIG. 3 is a transverse cross-sectional view of the swallow exerciserdevice of FIG. 1 taken along line 3-3 of FIG. 1.

FIG. 4 is a front view of a subject wearing a swallow exerciser deviceaccording to another embodiment of the invention.

FIG. 5 is a longitudinal cross-sectional view of the swallow exerciserdevice of FIG. 4 taken along line 5-5 of FIG. 4.

FIG. 6 is a transverse cross-sectional view of the swallow exerciserdevice of FIG. 4 taken along line 6-6 of FIG. 4.

FIG. 7 is a contour plot from the recording device of a high resolutionmanometry (HRM) system. The HRM recording device produces acolor-contour plot, with time on the x-axis, esophageal length on they-axis, and pressure represented by a color scale. In the right sideregion of FIG. 7, the position of the pharynx, and the upper esophagealsphincter (UES) are depicted.

FIG. 8 is a contour plot from the recording device of a high resolutionmanometry (HRM) system showing how contractile integral (CI) can bemeasured using an HRM system.

FIG. 9 is a plot from the recording device of a high resolutionmanometry (HRM) system showing how nadir sensor can be identified usingan HRM system.

FIG. 10 is a plot from the recording device of a high resolutionmanometry (HRM) system showing how nadir sensor contractile integral(CI) can be identified using an HRM system.

FIG. 11 shows an analysis of contractile integral (CI) slope.

FIG. 12 shows another analysis of contractile integral (CI) slope byage.

FIG. 13 shows another analysis of contractile integral (CI) slope byage.

FIG. 14 shows an analysis of contractile integral (CI) slope per swallowquartile. The bars reading left to right in each group of the graph arein the same order as the right hand legend reading top to bottom.

FIG. 15 shows another analysis of contractile integral (CI) slope perswallow quartile. The bars reading left to right in each group of thegraph are in the same order as the right hand legend reading top tobottom.

FIG. 16 shows another analysis of contractile integral (CI) slope perswallow quartile. The bars reading left to right in each group of thegraph are in the same order as the right hand legend reading top tobottom.

FIG. 17 shows graphs of the pharyngeal contractile integral (PhCI) withand without use of a swallow exerciser device of the present invention(referred to as a Resistance Exercise Device (RED) in FIG. 17).

FIG. 18 shows graphs of the effect of the swallow exerciser device ofthe invention (referred to as a Resistance Exercise Device (RED) in FIG.18) on pharyngeal peristalsis in sequential swallows.

FIG. 19 shows graphs of the effect of the swallow exerciser device ofthe invention (referred to as a Resistance Exercise Device (RED) in FIG.19) on pharyngeal peristalsis in sequential swallows. As seen by swallownumber 34 in FIG. 19, the pharyngeal peristaltic pressures havedecreased compared to earlier swallows indicating the fatigue of thepharyngeal muscles which is necessary for the muscles to strengthen byexercise.

FIG. 20 shows graphs of the effect with and without use of a swallowexerciser device of the invention (referred to as a Resistance ExerciseDevice (RED) in FIG. 20) on pharyngeal contraction in the proximalpharynx.

FIG. 21 shows graphs of the effect with and without use of a swallowexerciser device of the invention (referred to as a Resistance ExerciseDevice (RED) in FIG. 21) on pharyngeal contraction.

FIG. 22 shows graphs of the effect with and without use of a swallowexerciser device of the invention (referred to as a Resistance ExerciseDevice (RED) in FIG. 22) on the onset of fatigue.

FIG. 23 shows graphs of the effect of exerciser load of the swallowexerciser device of the invention on the pharyngeal contractile integral(PhCI) with and without use of the swallow exerciser device of thepresent disclosure.

Like reference numerals will be used to refer to like parts from Figureto Figure in the following description of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

Looking at FIGS. 1 to 3, there is shown a swallow exerciser device 10according to one non-limiting embodiment of the invention positioned onthe neck 13 of a human subject 21. The human subject 21 has anatomicalfeatures shown including a larynx 12, a neck 13, a tongue 14, a pharynx15, hyoid bone 16, cricoid cartilage 17, thyroid cartilage 18 (Adam'sapple), and an esophagus 19. The swallow exerciser device 10 shown has ashell 23, an adjustable fastener 30, and an inflation apparatus 50 forinflating and deflating an inflatable pad 37.

The shell 23 in the non-limiting embodiment shown has a generally ovalperimeter edge 27. The shell 23 has a distal surface 24 and a proximalsurface 25. The shell 23 may comprise a rigid polymeric material such asa polyolefin (e.g., polyethylene, polypropylene), a polyurethane, or apolycarbonate. The thickness of the shell 23 may be, for example, 1 to 5millimeters.

In one embodiment, the shell 23 has an overall longitudinal dimensiontaken along its longitudinal axis L (see FIG. 1) such that the shell 23extends above the larynx 12 of the subject 21 and extends below thelarynx 12 of the subject 21. In another embodiment, the shell 23 has anoverall longitudinal dimension taken along the longitudinal axis L suchthat the shell 23 extends from cricoid cartilage 17 to thyroid cartilage18 of the subject 21. In another embodiment, the shell 23 has an overalllongitudinal dimension taken along the longitudinal axis L such that theshell 23 extends from cricoid cartilage 17 to above a hyoid bone 16 ofthe subject 21. In another embodiment, the shell 23 has an overalllongitudinal dimension taken along the longitudinal axis L of about 5centimeters. In another embodiment, the shell 23 has an overalllongitudinal dimension taken along the longitudinal axis L of about 4centimeters. In another embodiment, the shell 23 has an overalllongitudinal dimension taken along the longitudinal axis L of about 3centimeters. In another embodiment, the shell 23 has a transversedimension taken along the transverse axis T (see FIG. 1) of about 2 toabout 5 centimeters.

Referring to FIG. 2, a longitudinal cross-sectional view of the swallowexerciser device 10 shows one non-limiting example positioning of theswallow exerciser device 10 with relation to several anatomicalfeatures. As can be seen, the longitudinally concave shell 23 extendsfrom below the cricoid cartilage 17 to above the hyoid bone 16. When inuse during a swallow, an external pressure applied to the subject's neckvia the swallow exerciser device 10 provides resistance to the larynx 12and hyoid 16 being drawn superiorly and anteriorly by swallowingmuscles.

As shown in FIG. 2, a longitudinal cross-section of the proximal surface25 of the shell 23 taken along the longitudinal axis L of the shell 23is concave. In one embodiment, the longitudinal cross-section of theproximal surface 25 of the shell 23 taken along longitudinal axis L ofthe shell 23 is concave along an entire length of the longitudinalcross-section.

As shown in FIG. 3, a transverse cross-section of the proximal surface25 of the shell 23 is concave. The transverse cross-section of theproximal surface 25 of the shell 23 taken along a transverse axis T (seeFIG. 1) of the shell 23 is concave along an entire length of thetransverse cross-section. In one embodiment, the longitudinalcross-section of the proximal surface 25 is less concave than thetransverse cross-section of the proximal surface 25.

Referring to FIGS. 1 and 3, the adjustable fastener 30 of the exerciserdevice 10 comprises a first band 31 attached on one side of theperimeter edge 27 of the shell 23 and a second band 32 attached on anopposite side of the perimeter edge 27 of the shell 23. The first band31 has a hook-type fastener component 34 at its distal end section, andthe second band 32 has a loop-type fastener component 33 at its distalend section. The hook and loop fastener arrangement may be one soldunder the trademark Velcro. The adjustable fastener 30 allows the shellto be secured around the neck 13 of the subject 21 as shown in FIGS. 1and 2 via the hook and loop fastener arrangement.

The inflatable pad 37 is secured to the shell 23 in an indentation 26 inthe distal surface 24 of the shell 23. The inflation apparatus 50includes a pump 51, a conduit 52 which allows for fluid (e.g., air) flowbetween the pump 51 and the inflatable pad 37, and a valve 53 forregulating inflation and deflation of the pad 37. Additionally, apressure gage 54 is used to measure a pressure level in the pad 37. Theinflatable pad 37 is in fluid communication with a port 38 forreleasably connecting the conduit 52 when inflating and deflating theinflatable pad 37. The port 38 may also include a valve for controllingthe flow of air into the inflatable pad 37. The inflatable pad 37 can beinflated by squeezing the pump 51 which can be in the form of a bulb.The pressure produced by inflatable pad 37 can then be read using thegage 54. The gage 54 may be connected via a tube that is long enough forthe subject to be able to read the gage 54. In other implementations,the bulb-type pump 51 may be replaced with means to automatically insertpressurized air into inflatable pad 37, such as an air pump.

In the non-limiting embodiment of the swallow exerciser device 10 inFIGS. 1-3, a viscoelastic layer 40 is attached to a proximal side of theinflatable pad 37. The viscoelastic layer may comprise a shape memoryfoam. The memory foam may be a viscoelastic open cell polyurethane foamwhich softens in reaction to body heat, allowing it to mold to a warmbody in a few minutes. Some memory foam attributes includeviscoelasticity which allows the foam to compress gradually, and memory,which means the foam returns to shape gradually. The thickness of theviscoelastic layer 40 may be, for example, 5 to 10 millimeters.

In the embodiment of the swallow exerciser device 10 in FIGS. 1-3, theproximal layer 42 covers a proximal side of the viscoelastic layer 40.In one non-limiting form, the proximal layer 42 comprises a fabric suchas a washable, woven or knitted material. Example materials suitable forthe fabric include synthetic fibers, natural fibers, and combinationsthereof, further including cottons, poly/cottons, fleeces, wools,flannels, polyesters, nylons, etc. A preferred fabric is soft andcomfortable.

The inflatable pad 37 is dimensioned to apply resistance to force of atleast one swallowing muscle of the subject when the shell 23 positionedover the larynx of the subject and when the inflatable pad is in aninflated position. The inflatable pad 37 may apply resistance to forceof at least one muscle of the tongue of the subject. The inflatable pad37 may apply resistance to force of at least one suprahyoid muscle ofthe subject. The inflatable pad 37 may apply resistance to force of atleast one of the digastric muscle, geniohyoid, and mylohyoid of thesubject. The inflatable pad 37 may apply resistance to force of at leastone infrahyoid muscle of the subject. The inflatable pad 37 may applyresistance to force of at least one suprahyoid muscle of the subject.The inflatable pad 37 may apply resistance to force of at least onemuscle of a longitudinal muscle group (e.g., palatopharyngeus,stylopharyngeus and salpingopharyngeus) of the subject. The inflatablepad 37 may apply resistance to force of at least one pharyngealconstrictor muscle (superior pharyngeal constrictor muscle, middlepharyngeal constrictor muscle, inferior pharyngeal constrictor muscle)of the subject.

In the swallow exerciser device 10, the inflatable pad 37 can bedimensioned to increase resistance to a flow of swallowed food out of apharynx of the subject when the shell 23 is positioned over the larynxof the subject and when the inflatable pad is in the inflated position.The inflatable pad 37 can be dimensioned to apply resistance to superiorand anterior movement of the larynx of the subject when the shell ispositioned over the larynx of the subject and when the inflatable pad isin the inflated position. The inflatable pad 37 can be dimensioned toapply resistance to superior movement of a hyoid bone of the subjectwhen the shell is positioned over the larynx of the subject and when theinflatable pad is in the inflated position. The inflatable pad 37 can bedimensioned to avoid applying pressure to a carotid artery of thesubject when the shell positioned over the larynx of the subject andwhen the inflatable pad is in the inflated position. The inflatable pad37 can be dimensioned to avoid applying pressure to a jugular vein ofthe subject when the shell positioned over the larynx of the subject andwhen the inflatable pad is in the inflated position.

Thus, a swallow exerciser device has been developed that exercises andthereby strengthens the muscles involved in swallowing by making them“work harder”. In one non-limiting example embodiment, the swallowexerciser device is 10-15 centimeters long and is placed around the neckcovering the larynx extending 1-2 centimeters above and below thelarynx. The swallow exerciser device includes rigid plastic shell withan indentation on the proximal (“patient”) side which accommodates theinflatable pad. The pad can be inflated to apply graded amounts (e.g.,10-30 mm Hg) of pressure, as determined with a hand-held pressure gage.When the subjects swallow, this pressure induces graded degrees ofresistance as the muscles of swallowing contract. These muscles can beof groups such as: (a) internal muscles of the oral cavity (e.g.pharynx, tongue, palate, etc.), and (b) external muscles (suprahyoid andthyrohyoid). The swallow exerciser device also induces resistance to theflow of swallowed material out of pharynx and into the esophagus.

Once the swallow exerciser device is fitted, the users participate in anexercise regimen. For example, 10 mm Hg is applied via the inflatablepad and the user swallows (or attempts to swallow, depending on his/hercapabilities) thirty times at ten second intervals. This exercise set isrepeated three times, three times per day for two weeks. The inflatablepad pressure is then increased to 20 mm Hg for the next two week cycle,and to 30 mm Hg for the following two week cycle and for future cycles.In another example, subjects will swallow repeatedly at a 30 secondinterval, morning, noon and in the evening for the lowest devicepressure for a number of weeks (e.g., 2 weeks). Then the device pressurewill be increased to the next level doing the same protocol for a numberof weeks and so on.

Referring now to FIGS. 4-6, there is shown a swallow exerciser device110 according to another non-limiting embodiment of the inventionpositioned on the neck 13 of a human subject 21. The human subject 21has anatomical features shown including a larynx 12, a neck 13, a tongue14, a pharynx 15, hyoid bone 16, cricoid cartilage 17, thyroid cartilage18 (Adam's apple), and an esophagus 19. The swallow exerciser device 110shown has a shell 123, an adjustable fastener 130, a spacer bar 144, andan inflation apparatus 50 for inflating and deflating an inflatable pad137.

The shell 123 in the non-limiting embodiment shown has a generally ovalperimeter edge 127. The shell 123 has a distal surface 124 and aproximal surface 125. The shell 123 may comprise a rigid polymericmaterial such as a polyolefin (e.g., polyethylene, polypropylene), apolyurethane, or a polycarbonate. The thickness of the shell 123 may be,for example, 1 to 5 millimeters.

In one embodiment, the shell 123 has an overall longitudinal dimensiontaken along its longitudinal axis L (see FIG. 4) such that the shell 123extends above the larynx 12 of the subject 21 and extends below thelarynx 12 of the subject 21. In another embodiment, the shell 123 has anoverall longitudinal dimension taken along the longitudinal axis L suchthat the shell 123 extends from cricoid cartilage 17 to thyroidcartilage 18 of the subject 21. In another embodiment, the shell 123 hasan overall longitudinal dimension taken along the longitudinal axis Lsuch that the shell 123 extends from cricoid cartilage 17 to above ahyoid bone 16 of the subject 21. In another embodiment, the shell 123has an overall longitudinal dimension taken along the longitudinal axisL of about 5 centimeters. In another embodiment, the shell 123 has anoverall longitudinal dimension taken along the longitudinal axis L ofabout 4 centimeters. In another embodiment, the shell 123 has an overalllongitudinal dimension taken along the longitudinal axis L of about 3centimeters. In another embodiment, the shell 123 has a transversedimension taken along the transverse axis T (see FIG. 4) of about 2 toabout 5 centimeters.

Referring to FIG. 5, a longitudinal cross-sectional view of the swallowexerciser device 110 shows one non-limiting example positioning of theswallow exerciser device 110 with relation to several anatomicalfeatures. As can be seen, the longitudinally concave shell 123 extendsfrom below the cricoid cartilage 17 to above the hyoid bone 16. When inuse during a swallow, an external pressure applied to the subject's neckvia the swallow exerciser device 110 provides resistance to the larynx12 and hyoid 16 being drawn superiorly and anteriorly by swallowingmuscles.

As shown in FIG. 5, a longitudinal cross-section of the proximal surface125 of the shell 123 taken along the longitudinal axis L of the shell123 is concave. In one embodiment, the longitudinal cross-section of theproximal surface 125 of the shell 123 taken along longitudinal axis L ofthe shell 123 is concave along an entire length of the longitudinalcross-section.

As shown in FIG. 6, a transverse cross-section of the proximal surface125 of the shell 123 is concave. The transverse cross-section of theproximal surface 125 of the shell 123 taken along a transverse axis T(see FIG. 4) of the shell 123 is concave along an entire length of thetransverse cross-section. In one embodiment, the longitudinalcross-section of the proximal surface 125 is less concave than thetransverse cross-section of the proximal surface 125.

Referring to FIGS. 4 and 6, the adjustable fastener 130 of the exerciserdevice 110 comprises a band 131 that has a hook-type fastener component134 at its distal end section and a loop-type fastener component 133 atits distal end section. The hook and loop fastener arrangement may beone sold under the trademark Velcro. The adjustable fastener 130 allowsthe shell to be secured around the neck 13 of the subject 21 as shown inFIGS. 4 and 5 via the hook and loop fastener arrangement.

The spacer bar 144 is attached to the shell 123 and/or the band 131, andis positioned between the shell 123 and the band 131 as shown in FIGS.4-6. In one non-limiting example form, the spacer bar 144 has an overalllongitudinal dimension taken along the longitudinal axis L (see FIG. 4)of about 3 to about 5 centimeters, a thickness of about 1 to about 2centimeters, and a transverse dimension taken along the transverse axisT (see FIG. 4) of about 1 to about 2 centimeters. The spacer bar 144 ispreferably spaced inward from the perimeter edge 127 of the shell 123.The spacer bar 144 serves to bridge the band 131 over the neck vitalorgans and prevent pressuring them. For example, the spacer bar 144serves to bridge the band 131 over a carotid artery of the subject and ajugular vein of the subject when the shell is positioned over the larynxof the subject and when the inflatable pad is in the inflated positionsuch that the carotid artery and the jugular vein of the subject are notpressured.

The inflatable pad 137 is secured to the shell 123 in an indentation 126in the distal surface 124 of the shell 123. The inflation apparatus 50includes a pump 51, a conduit 52 which allows for fluid (e.g., air) flowbetween the pump 51 and the inflatable pad 137, and a valve 53 forregulating inflation and deflation of the pad 137. Additionally, apressure gage 54 is used to measure a pressure level in the pad 137. Theinflatable pad 137 is in fluid communication with a port 138 forreleasably connecting the conduit 52 when inflating and deflating theinflatable pad 137. The port 138 may also include a valve forcontrolling the flow of air into the inflatable pad 137. The inflatablepad 137 can be inflated by squeezing the pump 51 which can be in theform of a bulb. The pressure produced by inflatable pad 137 can then beread using the gage 54. The gage 54 may be connected via a tube that islong enough for the subject to be able to read the gage 54. In otherimplementations, the bulb-type pump 51 may be replaced with means toautomatically insert pressurized air into inflatable pad 137, such as anair pump.

In the non-limiting embodiment of the swallow exerciser device 110 inFIGS. 4-6, a viscoelastic layer 140 is attached to a proximal side ofthe inflatable pad 137. The viscoelastic layer may comprise a shapememory foam. The memory foam may be a viscoelastic open cellpolyurethane foam which softens in reaction to body heat, allowing it tomold to a warm body in a few minutes. Some memory foam attributesinclude viscoelasticity which allows the foam to compress gradually, andmemory, which means the foam returns to shape gradually. The thicknessof the viscoelastic layer 140 may be, for example, 5 to 10 millimeters.

In the embodiment of the swallow exerciser device 110 in FIGS. 4-6, theproximal layer 142 covers a proximal side of the viscoelastic layer 140.In one non-limiting form, the proximal layer 142 comprises a fabric suchas a washable, woven or knitted material. Example materials suitable forthe fabric include synthetic fibers, natural fibers, and combinationsthereof, further including cottons, poly/cottons, fleeces, wools,flannels, polyesters, nylons, etc. A preferred fabric is soft andcomfortable.

The inflatable pad 137 is dimensioned to apply resistance to force of atleast one swallowing muscle of the subject when the shell 123 positionedover the larynx of the subject and when the inflatable pad is in aninflated position. The inflatable pad 137 may apply resistance to forceof at least one muscle of the tongue of the subject. The inflatable pad137 may apply resistance to force of at least one suprahyoid muscle ofthe subject. The inflatable pad 137 may apply resistance to force of atleast one of the digastric muscle, geniohyoid, and mylohyoid of thesubject. The inflatable pad 137 may apply resistance to force of atleast one infrahyoid muscle of the subject. The inflatable pad 137 mayapply resistance to force of at least one suprahyoid muscle of thesubject. The inflatable pad 137 may apply resistance to force of atleast one muscle of a longitudinal muscle group (e.g., palatopharyngeus,stylopharyngeus and salpingopharyngeus) of the subject. The inflatablepad 137 may apply resistance to force of at least one pharyngealconstrictor muscle (superior pharyngeal constrictor muscle, middlepharyngeal constrictor muscle, inferior pharyngeal constrictor muscle)of the subject.

In the swallow exerciser device 110, the inflatable pad 137 can bedimensioned to increase resistance to a flow of swallowed food out of apharynx of the subject when the shell 123 is positioned over the larynxof the subject and when the inflatable pad is in the inflated position.The inflatable pad 137 can be dimensioned to apply resistance tosuperior and anterior movement of the larynx of the subject when theshell is positioned over the larynx of the subject and when theinflatable pad is in the inflated position. The inflatable pad 137 canbe dimensioned to apply resistance to superior movement of a hyoid boneof the subject when the shell is positioned over the larynx of thesubject and when the inflatable pad is in the inflated position. Theinflatable pad 137 can be dimensioned to avoid applying pressure to acarotid artery of the subject when the shell positioned over the larynxof the subject and when the inflatable pad is in the inflated position.

Once the swallow exerciser device 110 is fitted, the users participatein an exercise regimen such as that described above for the swallowexerciser device 10.

EXAMPLES

The following Examples are provided in order to demonstrate and furtherillustrate certain embodiments and aspects of the present invention andare not to be construed as limiting the scope of the invention.

Data provided in the Examples demonstrates that exercise using theswallow exerciser device of the invention fatigues both the pharynx aswell as the proximal striated esophagus thereby setting them up to bestrengthened based on the proven and accepted notion in exercisephysiology that exercises causing fatigue in the muscle result instrengthening of the muscle.

Example 1 Overview of Example 1

A swallow exerciser device of the present disclosure was shown to beeffective for inducing fatigue in pharyngeal peristalsis. Fatigue isimportant because based on exercise physiology principles, musclesstrengthen when they are fatigued by exercise.

Eleven healthy subjects (age 56±25 years, 6 female) were studied. Themethods of this Example are based on fundamental deglutitivebiomechanics wherein one of the prominent features of swallowing isanterior and superior movement of the hyoid and larynx. Compromisedanterior and superior movement of the hyo-laryngeal complex has beenshown in the elderly (see, Kern M, Bardan E, Arndorfer R, Hofmann C, RenJ, Shaker R., Ann Otol Rhinol Laryngol. 1999 October; 108(10):982-9; andYokoyama M, Mitomi N, Tetsuka K, Tayama N, Niimi S., Laryngoscope 2000March; 110(3 Pt 1):434-9; and Barikroo A, Carnaby G, Crary M., Dysphagia2015 Jul. 11) as well as in patients with dysphagia of varying etiology(see, Paik N J, Kim S J, Lee H J, Jeon J Y, Lim J Y, Han T R., JElectromyogr Kinesiol. 2008 April; 18(2):329-35) including stroke (KimY, McCullough G H., Dysphagia 2010 March; 25(1):20-5) and cancertreatment. Dysphagia treatment using exercise has ranged fromisotonic-isometric head raising (Shaker R, Kern M, Bardan E, Taylor A,Stewart E T, Hoffmann R G, Arndorfer R C, Hofmann C, Bonnevier J., Am JPhysiol. 1997 June; 272(6 Pt 1):G1518-22; and Shaker R, Easterling C,Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, DikemanK., Gastroenterology 2002 May; 122(5):1314-21) to repeated effortfulswallowing (Jang H J, Leigh J H, Seo H G, Han T R, Oh B M., J OralRehabil. 2015 May 25). These exercise regimens have been successful forimproving swallowing performance in some patient groups, especiallythose patients wherein the primary cause of symptoms is associated withcompromised upper esophageal sphincter (UES) opening. Given theprominent role of anterior and superior movement of the hyo-laryngealcomplex during swallowing, the focus of the swallow exerciser devicedisclosed herein is to provide a resistive load to anterior and superiorlaryngeal movement thereby fatiguing muscle groups associated withdeglutitive laryngeal movement. Effective and focused fatigue acts as atraining mechanism for strengthening these muscle groups.

Resistance Exercise Device (RED)

In Example 1, we refer to a swallow exerciser device of the presentdisclosure as a Resistance Exercise Device (RED). To increase the loadon the deglutitive muscles of the pharynx, a resistance exercise device(RED) was manufactured in our lab to provide an adjustable and fixedresistance to anterior and superior movement of the hyo-laryngealcomplex. The device comprised a cotton fabric strap 63.5 centimeters inlength and 2 centimeters in width. The ends of the strap were affixedwith VELCRO® brand hook and loop fastening strips 21 centimeters inlength to customize fitting of the RED when the strap is wrapped aroundthe neck. For an initial device prototype, the middle portion of thedevice had an additional cotton pad 30 centimeters in length and 5centimeters in width to provide support for the portion of the devicethat applies external force to the cricoid cartilage when positioned onthe subject. A concave, flexible plastic disk was affixed to the middleof the strap assembly. This concave disk was wrapped in tape and servesas a support structure for an inflatable polyethylene bag which acts toapply an external force to the cricoid cartilage to restrict anteriorand superior movement of the larynx. An inflatable bag was connected viaa flexible catheter assembly to a hand pump and pressure gauge. Duringproduction of this device, the bag is maximally inflated on the benchand loosely wrapped with soft tape and subsequently deflated. In thisway, the inflatable bag rests comfortably on the neck without skinirritation. The inflatable pad rests in a position on the cricoid fixedby closure of the VELCRO® brand hook and loop fastening straps. A knownexternal force may be applied to the cricoid by partially inflating thebag to a specific pressure reading on the gauge. The soft and compliantbag conforms to the surface of the skin cradling the irregular geometryof the cricoid while applying a resistive force to anterior and superiordistraction of the hyo-laryngeal complex during swallowing.

Pharyngeal and Proximal Esophageal Manometry

Pharyngeal and proximal esophageal pressure was monitored using a highresolution (HR) manometric catheter positioned transnasally to traversethe pharynx, upper esophageal sphincter (UES) and proximal esophagus.The HR probe and computerized recording and analysis system (ManoScanand ManoView Systems, Given Imaging, Inc., Duluth, Ga., USA) storespressure data from 36 pressure sensors (with 1 centimeter sensorspacing) on the HR probe, displays the manometric information intopographic or line graph formats as well as provides post-acquisitionanalytic tools for parameterization of temporal and spatial pressuredata.

Experimental Protocol

All subjects were seated in an upright position for the duration of thestudy. The subjects were verbally cued to perform 40 consecutiveswallows of 0.5 ml room temperature water while wearing the RED duringHR manometry. There was a 20 second interval between swallows whereinthe subject refrained from swallowing. The water bolus was slowlyinjected into the oral cavity by a syringe and the subject was then cuedto swallow the water in a single swallow. During these 40 swallows, theapplied external pressure was maintained at 40 mmHg as measured by theexternal RED pressure gauge. Following these swallows, the RED wasremoved and, after a 20 minute rest period, another 40 swallows with 20second intervals between swallows was recorded. During the 20 minuterest period, subjects remained seated with the manometric catheter inplace and were told to relax and swallow ad libitum.

Manometric Parameters of Fatigue

Several manometric parameters were measured and analyzed for eachswallow. Peak deglutitive peristaltic wave pressures were measured atpositions 2, 3, 4, 5, 6, 7 and 8 centimeters above the upper margin ofthe manometrically determined pharyngo-esophageal high pressure zone.The deglutitive UES nadir pressure was also measured. Additionally, aparameter derived from the ManoView analysis software was measured. Thepharyngeal contractile integral (PhCI) was calculated using the“SmartMouse” feature of the ManoView software. The contractile integraltechnique has been utilized in the distal esophagus as metric of“contractile vigor” (see, Lin Z, Roman S, Pandolfino J E, Kahrilas P J.,Neurogastroenterol Motil. 2012 January; 24(1):e4-10) by multiplying themean pressure amplitude times the contraction duration times the lengthof the region of interest. In the ManoView software topographic displayusing the computer's mouse, the contractile integral is calculated byscrolling out an area in the topographic display delineating aspace-time box and logging the displayed contractile integral value. Forthe purposes of our analysis, the PhCI was characterized bycircumscribing a space-time box in the topographic ManoView display tosurround the pharyngeal deglutitive pressure recording with the uppermargin of the box at the most proximal probe sensor at a time prior todeglutition and the distal margin of the box at the predetermined uppermargin of the UES high pressure zone at the time of return of the highpressure zone to its resting manometric profile.

Both the peak peristaltic pressures and the PhCI were used as manometricsurrogates for detecting fatigue due to repeated deglutitive pharyngealcontraction against the increased load provided by the RED. Thesemetrics were also evaluated for the swallow sequences without the RED.In a second order analysis, the linear regression slope and correlationcoefficient of the peak pressures and PhCI across sequential swallowswas evaluated wherein a significant negative correlation (or a negativeslope statistically different than zero) was associated with fatigue ofthe deglutitive pharyngeal muscles.

Statistical Analysis

Pearson correlation analysis was used to detect decreasing pharyngealpeak deglutitive peristaltic pressures and decreasing PhCI acrossconsecutive water swallows. Slope values were compared for theseparameters with and without the exerciser using the paired t-test.

Results

The pharyngeal contractile integrals showed slope differences betweenswallow tests with and without a swallow exerciser device of the presentdisclosure. Swallow against an increased external load induced by aswallow exerciser device of the present disclosure is effective forinducing fatigue in pharyngeal peristalsis.

Example 2 Overview of Example 2

Example 2 reports a study on the effect of a swallow exerciser device ofthe present disclosure on the proximal esophagus. Data in Example 2clearly shows fatigue of the proximal esophageal muscles by swallowingwhile wearing the swallow exerciser device. Fatigue is important becausebased on exercise physiology principles, muscles strengthen when theyare fatigued by exercise.

Among other things, the study of Example 2 sought to: (i) identifyobjective measurement parameters for proximal esophageal muscle; (ii)identify variability within measurement parameter methods, and (iii)observe any preliminary trends in the physiology and anatomy of proximalesophageal muscle response both with and without the swallow exerciserdevice.

Methods

A high resolution manometry (HRM) catheter was inserted through thenares of the patient and positioned so that it covered the entirepharynx (nasopharynx to proximal esophagus). The patient was situatedupright, and was fitted with the swallow exerciser device, which was setto 40 mmHg for the study, around the larynx. The patient was given 20minutes to adjust to catheter and swallow exerciser device. The patientwas prompted to conduct 40 wet swallows of 0.5 ml of water with theswallow exerciser device on. The swallow was prompted every 20 seconds.The swallow exerciser device pressure was reset to 0 mmHg and thepatient was given a 10 minute rest period. The patient was prompted toconduct 40 wet swallows of 0.5 ml of water without the swallow exerciserdevice on. The swallow was prompted every 20 seconds. Upon studyconclusion, the catheter and swallow exerciser device were removed. Allanalysis was conducted blindly in Manoview ESO 3.0 software.

The demographics of the study were: 15 studies; 8 young (<40, 5 male/3female); 6 elderly (>65, 1 male/5 female); 1 middle-age (41-64,male-male); all healthy; and 1 repeat (young).

Manometrically measured peristaltic pressure amplitude displays awell-defined trough called the “transition zone” (TZ). From manometry,the TZ center (nadir pressure amplitude) and the upper/lower margins ofthe pressure trough can quantified. Documented parameters of the studyof Example 2 were: (1) contractile integral (CI, mmHg*cm*s) from bottomof UES to 3 centimeters, 4 centimeters, and 5 centimeters below thebottom of UES (striated esophagus); (2) Nadir pressure sensor locationand pressure (TZ midpoint); and (3) CI from bottom of UES to nadirsensor location. Interpolated data was avoided for pressuremeasurements.

The margin was placed at the nearest centimeter outside of the restingUES 20 mmHg pressure zone. See FIG. 7.

FIG. 8 is a contour plot from the recording device of the HRM systemshowing how contractile integral (CI) was measured. Using a smart mouse,the CI at 20 mmHg was taken using: (a) the initiation of swallow as leftmargin; (b) the right most portion of striated swallow as right margin;(c) the lower margin of the UES as the top margin; and (d) the specifiedlength as the bottom margin.

FIG. 9 is a plot from the recording device of the HRM system showing hownadir sensor was identified, and FIG. 10 is a plot from the recordingdevice of the HRM system showing how nadir sensor contractile integral(CI) was identified. We established 10 channels, 1 centimeter spaced,starting from the UES lower margin of the HPZ. They were placed at theX.0 cm mark. On the channel display, we identified the channel with thesmallest peak pressure during the swallow. We repeated the contractileintegral (CI) method, this time with the nadir sensor serving as thelower margin of the contractile integral (CI) box. Any peak pressurebelow 0 mmHg was documented as 0 mmHg.

FIG. 11 shows an analysis of contractile integral (CI) slope. Wemeasured CI from the lower UES margin of the HPZ to 3 centimeters, 4centimeters, and 5 centimeters below the lower UES margin of the HPZ,and to the nadir sensor and CI was plotted per swallow with and withoutthe swallow exerciser device (rate of fatigue). The CI slope wascompared and the data (n=9) is shown in FIG. 11 where Sig.Correlat.=Significant Correlation. The contractile integral (CI) slopeby age was compared and the data (young n=7) is shown in FIG. 12. The CIslope by age was compared and the data (elderly n=6) is shown in FIG.13.

FIGS. 14 to 16 show our analyses of contractile integral (CI) slope perswallow quartile. Each set of 40 swallows (both with and without theswallow exerciser device) was separated into 4 quartiles of 10 swallowseach. The measured CI from the lower UES margin to 3 centimeters, 4centimeters, and 5 centimeters below the lower UES margin, and to thenadir sensor, and CI was plotted per swallow for the designatedquartile.

2-Person Inter-Observer Analysis: Out of the original 10, only 1 studyhad a different UES margin. CI average Correlation: 0.9568. Sensorselection average Correlation: 0.9855. Sensor Peak Pressure averageCorrelation: 0.8524. N=9 average correlation: 0.9039. N=10 w/ differentUES margin: 0.8921. N=10 w/ edited UES margin: 0.8987

CONCLUSIONS

As noted above, the pharyngeal contractile integral (PhCI) can be usedas a manometric surrogate for detecting fatigue due to the increasedload provided by the swallow exerciser device of the present disclosure.In Example 2, the contractile integral (CI) shows statisticallysignificant slope differences with a swallow exerciser device of thepresent disclosure, particularly in elderly subjects, suggestingfatigue. A potential pattern was exhibited in the CI quartile. Initialreview of the parameters reveals relatively low inter-observervariability. Thus, swallow against an increased external load induced bya swallow exerciser device of the present disclosure is effective forinducing fatigue in the proximal esophagus.

Example 3 Overview of Example 3

Example 3 reports a study on the effect of a swallow exerciser device ofthe present disclosure for swallowing on pharyngeal peristalsis. Data inExample 3 clearly shows fatigue of the pharyngeal muscles by swallowingwhile wearing the swallow exerciser device. The pharyngeal muscles canbe strengthened when they are fatigued by exercise.

INTRODUCTION

The oral/pharyngeal phase of swallowing involves complex interactionsbetween lingual, pharyngeal, oral, cervical and laryngeal muscles. Inaddition to precise coordination, adequate contractile function of thesemuscles are crucial for normal transport of the swallowed bolus out ofthe pharynx and into the esophagus. The elements involved in a normaloral/pharyngeal phase of swallowing include: (i) motor function (tongueand pharynx); (ii) relaxation/opening (UES, suprahyoid muscles); (iii)airway closure (larynx, velopharynx); (iv) sensory function; and (v)coordination and timing. Weakness of the oropharyngeal musculatureincluding the pharyngeal constrictors commonly occurs following stroke,radiation and surgical therapy. Weakness of pharyngeal peristalsis canresult in dysphagia, post deglutitive residue, aspiration, andaspiration pneumonia. Various exercises have been shown to strengthencomponents of the oropharyngeal deglutitive apparatus such as thesupra-hyoid UES opening muscles and the tongue. Options directly aimedat improving the contractile function of the pharynx however, arecurrently limited.

We hypothesized that repetitive swallowing against an increased loadinduced externally will result in fatigue of the pharyngeal muscles asevidenced by decrease in the peak amplitude of pharyngeal peristalticpressure waves and that exercise induced muscle fatigue could yieldstrengthening that could improve pharyngeal function.

Among other things, the study of Example 3 sought to determine theeffect of increased swallow load induced by applying resistance to theanterior and superior excursions of the hyo-laryngeal complex on theparameters of the pharyngeal peristaltic pressure waves.

Methods

We studied 15 healthy individuals of age 56±25 years (7 female) in anupright position. Pharyngeal peristalsis was recorded using an HRMcatheter that covered the entire length of the pharynx, UES, andproximal esophagus. A reduction in the amplitude of pharyngealperistalsis was considered as a surrogate for fatigue.

To increase the swallow load externally, we used a swallow exerciserdevice of the present disclosure that due to its configuration caninduce graded resistance to the anterior and superior excursion of thehyo-laryngeal complex during swallowing. In Example 3 and its associatedFIGS. 17-23, we refer to a swallow exerciser device of the presentdisclosure as a Resistance Exercise Device (RED).

We recorded pharyngeal peristalsis during 40 consecutive swallows of 0.5ml water in 20 second intervals while subjects wearing the RED set at 40mmHg pressure. This was followed after 15 minutes of rest by 40 swallowsof the same volume and interval without the RED.

Parameters of interest included: (i) peak pharyngeal peristalticpressures at 3, 4, 5, 6, 7 and 8 centimeters above the upper margin ofpharyngo-esophageal high pressure zone (PE-HPZ), and (ii) pharyngealcontractile integral (PhCI). For statistical analyses, we used Pearsoncorrelation, intra-class correlation and Student's t-test.

Results

We analyzed the effect of the Resistance Exercise Device (RED) on thepharyngeal contractile integral (PhCI). There is a progressive decreasein PhCI for sequential swallows while wearing the RED. See FIG. 17.

We analyzed the effect of the Resistance Exercise Device (RED) onpharyngeal contraction. The peak pressure of sequential swallows can becompared, see FIGS. 18-19. As seen by swallow number 34 in FIG. 19, thepharyngeal peristaltic pressures have decreased compared to earlierswallows indicating the fatigue of the pharyngeal muscles which isnecessary for the muscles to strengthen by exercise.

Referring to FIG. 20, there is shown peak deglutitive peristaltic waveamplitudes 8 centimeters above the upper margin of the PE-HPZ. There isa progressive decrease in peak pressure at this location for sequentialswallows while wearing the RED. This decrease is absent for successiveswallows without the RED.

Referring now to FIG. 21, there is shown all subjects data for therecording site 8 centimeters above the upper margin of the PE-HPZ. Tofit all data on the same scale, pressure data is normalized to the meanpressure for site 8 centimeters within each subject across each 40swallow sequence. Individual subject data is represented as differentcolors and symbols. The regression line represents fitting of the meandata across subjects.

Since PhCI reflects the pressure phenomena across the entire pharynx,further analysis revealed that the fatigue trend significantly affectedsome but not all of the recording sites. A one sample t-test was used totest to determine whether correlation coefficients are significantlydifferent from zero with the listed probability of Type I error. SeeTable 1 below.

TABLE 1 With RED (Sites) Z scored correlation coefficient P value P2 0.07 ± 0.46 0.74 P3 −0.21 ± 0.39 0.56 P4 −0.09 ± 0.31 0.27 P5 −0.17 ±0.53 0.21 P6 −0.28 ± 0.58 0.05 P7 −0.41 ± 0.59 0.03* P8 −0.56 ± 0.340.003*

We analyzed the effect of sham resistance exercise on pharyngealcontraction. Fatigue behavior was not seen in swallow sequences withoutthe exerciser. A one sample t-test was used to test whether correlationcoefficients are significantly different from zero with the listedprobability of Type I error. See Table 2 below.

TABLE 2 Without RED (Sites) Z scored correlation coefficient P value P20.04 ± 0.38 0.94 P3 −0.11 ± 0.28  0.10 P4 0.04 ± 0.33 0.45 P5 0.15 ±0.32 0.45 P6 0.14 ± 0.62 0.58 P7 0.14 ± 0.62 0.53 P8 −0.002 ± 0.42  0.64

We analyzed the onset of fatigue. A set of 40 swallows was partitionedinto 5 swallow epochs. Then, 5 swallows were averaged in each epoch.ANOVA average PhCI was tested across epochs and across all subjects.Significant differences across epochs were seen for PhCI with the REDbut not without the RED. Differences were driven by significantdifference in epoch 2 compared to epoch 8 (p=0.0115). Epoch-wise testswere corrected for multiple comparisons. See FIG. 22.

We also analyzed the effect of exerciser load of the swallow exerciserdevice of the invention on the pharyngeal contractile integral (PhCI)with and without use of the swallow exerciser device. See FIG. 23.

Conclusions from Example 3

Swallow against an increased external load induced by a swallowexerciser device of the present disclosure is safe and effective forinducing fatigue in pharyngeal peristalsis and thus can strengthen thepharyngeal constrictor muscles. This finding provides an opportunity fortreatment of pharyngeal weakness observed in patients withoro-pharyngeal dysphagia.

Thus, the invention provides a swallow exerciser device that exercisesand thereby strengthens the muscles involved in swallowing.

Although the invention has been described in considerable detail withreference to certain embodiments, one skilled in the art will appreciatethat the present invention can be practiced by other than the describedembodiments, which have been presented for purposes of illustration andnot of limitation. Therefore, the scope of the appended claims shouldnot be limited to the description of the embodiments contained herein.

What is claimed is:
 1. A method for improving swallowing function in asubject, the method comprising: positioning a swallow exerciser deviceover the larynx of the subject, the device including (i) a shell havinga longitudinal dimension such that the shell extends above a larynx ofthe subject and extends below the larynx of the subject, the shellhaving a distal surface and a proximal surface, (ii) an adjustablefastener dimensioned to secure the shell around a neck of the subjectwith the shell positioned over the larynx of the subject, and (iii) aninflatable pad connected to the proximal surface of the shell, theinflatable pad being dimensioned to apply resistance to force of atleast one swallowing muscle of the subject when the shell is positionedover the larynx of the subject and when the inflatable pad is in aninflated position, wherein the subject swallows after positioning thedevice over the larynx of the subject.
 2. The method of claim 1 wherein:the adjustable fastener is connected to the shell.
 3. The method ofclaim 1 wherein: a spacer positioned between the shell and theadjustable fastener, the spacer being attached to the shell and/or theadjustable fastener.
 4. The method of claim 1 wherein: the spacer isinwardly spaced from a perimeter edge of the shell.
 5. The method ofclaim 1 wherein: when the inflatable pad is in the inflated position,the inflatable pad exerts pressure between the shell and the neck of thesubject in a pressure range of 10 to 50 mm Hg.
 6. The method of claim 1wherein: when the inflatable pad is in the inflated position, theinflatable pad exerts pressure between the shell and the neck of thesubject in a pressure range of 10 to 40 mm Hg.
 7. The method of claim 1wherein: when the inflatable pad is in the inflated position, theinflatable pad exerts pressure between the shell and the neck of thesubject in a pressure range of 10 to 30 mm Hg.
 8. The method of claim 1further comprising: increasing a pressure in the inflatable pad afterthe subject swallows at least one time.
 9. The method of claim 1 furthercomprising: removing the device after the subject swallows at least onetime with a first pressure in the inflatable pad; and positioning theswallow exerciser device over the larynx of the subject a second timewith a second pressure in the inflatable pad, wherein the secondpressure is greater than the first pressure.
 10. The method of claim 9further comprising: removing the device after the subject swallows atleast one time with the second pressure in the inflatable pad; andpositioning the swallow exerciser device over the larynx of the subjecta third time with a third pressure in the inflatable pad, wherein thethird pressure is greater than the second pressure.
 11. The method ofclaim 1 wherein: the device is positioned such that the shell extendsabout 1 to 2 centimeters above the larynx and the shell extends about 1to 2 centimeters below the larynx.
 12. The method of claim 1 wherein:the device is positioned such that the inflatable pad applies resistanceto force of at least one muscle of the tongue of the subject when theinflatable pad is in the inflated position.
 13. The method of claim 1wherein: the device is positioned such that the inflatable pad appliesresistance to force of at least one suprahyoid muscle of the subjectwhen the inflatable pad is in the inflated position.
 14. The method ofclaim 1 wherein: the device is positioned such that the inflatable padapplies resistance to force of at least one infrahyoid muscle of thesubject when the inflatable pad is in the inflated position.
 15. Themethod of claim 1 wherein: the device is positioned such that theinflatable pad applies resistance to force of at least one of thepalatopharyngeus, stylopharyngeus and salpingopharyngeus of the subjectwhen the inflatable pad is in the inflated position.
 16. The method ofclaim 1 wherein: the device is positioned such that the inflatable padapplies resistance to force of at least one pharyngeal constrictormuscle of the subject when the inflatable pad is in the inflatedposition.
 17. The method of claim 1 wherein: the method fatigues apharynx of the subject.
 18. The method of claim 1 wherein: the methodfatigues a proximal striated esophagus of the subject.
 19. The method ofclaim 1 wherein: the method fatigues both a pharynx and a proximalstriated esophagus of the subject.
 20. The method of claim 1 wherein:the method provides a resistive load to anterior and superior movementof a hyoid and a larynx of the subject.